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NDC 57483-0955-05 Allervarx 5 mg/1 Details

Allervarx 5 mg/1

Allervarx is a ORAL TABLET, ORALLY DISINTEGRATING in the HUMAN OTC DRUG category. It is labeled and distributed by Innovus Pharmaceuticals, Inc.. The primary component is LORATADINE.

MedlinePlus Drug Summary

Loratadine is used to temporarily relieve the symptoms of hay fever (allergy to pollen, dust, or other substances in the air) and other allergies. These symptoms include sneezing, runny nose, and itchy eyes, nose, or throat. Loratadine is also used to treat itching and redness caused by hives. However, loratadine does not prevent hives or other allergic skin reactions. Loratadine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms. Loratadine is also available in combination with pseudoephedrine (Sudafed, others). This monograph only includes information about the use of loratadine alone. If you are taking the loratadine and pseudoephedrine combination product, read the information on the package label or ask your doctor or pharmacist for more information.

Related Packages: 57483-0955-05
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Loratadine

Product Information

NDC	57483-0955
Product ID	57483-955_75ab8cfc-561a-4990-b19c-2a5740d953f6
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Allervarx
Proprietary Name Suffix	n/a
Non-Proprietary Name	Loratadine
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, ORALLY DISINTEGRATING
Route	ORAL
Active Ingredient Strength	5
Active Ingredient Units	mg/1
Substance Name	LORATADINE
Labeler Name	Innovus Pharmaceuticals, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA212795
Listing Certified Through	2024-12-31

Package

Package Images

NDC 57483-0955-05 (57483095505)

Pricing Information	N/A
NDC Package Code	57483-955-05
Billing NDC	57483095505
Package	3 BLISTER PACK in 1 CARTON (57483-955-05) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Marketing Start Date	2022-08-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ec4d1e77-6995-4228-8e63-a9ab6232dace Details

Active ingredient (in each tablet)

Loratadine 5 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory

allergies:

runny nose
itchy, watery eyes
sneezing
itching of the nose or throat

Warnings

Do not use

if you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you have

liver or kidney disease. Your doctor should determine if you need a different dose.

When using this product

do not take more than directed. Taking more than directed may cause drowsiness.

Stop use and ask a doctor if

an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding

ask a health professional before use.

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

place 1 tablet on tongue; tablet disintegrates, with or without water


adults and children 6 years and over	1 tablet every 12 hours; not more than 2 tablets in 24 hours
children under 6 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Other Information

Safety sealed: do not use if the individual blister unit imprinted with Loratadine Orally Disintegrating Tablet, USP is open or torn
store between 20° to 25°C (68° to 77°F)
use tablet immediately after opening individual blister
complies with USP Procedure 2 for Assay and Organic Impurities and Test 2 for Disintegration

Inactive ingredients

anhydrous citric acid, mannitol, peppermint flavor, polysorbate 80, pullulan

Questions or comments?

1-888-278-1784 - Our Medical Information center shall operate between 9:00 AM to 5:00 PM EST from Monday through Friday (business hours). Queries received outside business hours shall reach voice mail and shall be attended on next business day.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALLERVARX

loratadine tablet, orally disintegrating

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57483-955
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	5 mg

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
PULLULAN (UNII: 8ZQ0AYU1TT)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
MANNITOL (UNII: 3OWL53L36A)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	12mm
Flavor	PEPPERMINT	Imprint Code	T5
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:57483-955-05	3 in 1 CARTON	08/01/2022
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA212795	06/04/2022

Labeler - Innovus Pharmaceuticals, Inc. (962507187)

Name	Address	ID/FEI	Business Operations
Establishment
Tenshi Kaizen Pvt Ltd		675478488	manufacture(57483-955) , pack(57483-955) , analysis(57483-955)

Revised: 6/2022

Document Id: 75ab8cfc-561a-4990-b19c-2a5740d953f6

Set id: ec4d1e77-6995-4228-8e63-a9ab6232dace

Version: 1

Effective Time: 20220604